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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NamePROXIMAL INTERPHALANGEAL (PIP) FINGER JOINT
Classification Namesemi-constrained metal/polymer finger joint prosthesis
Generic Namesemi-constrained metal/polymer finger joint prosthesis
Applicant
Encore Medical L/P. D/B/A Djo Surgical
9800 metric blvd.
austin, TX 78758
HDE NumberH980002
Supplement NumberS001
Date Received02/26/1999
Decision Date08/26/1999
Product Code
MPK[ Registered Establishments with MPK ]
Advisory Committee Orthopedic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a line extension of the a vanta pip prosthesis. The avanta pip joint prosthesis is indicated for use in arthroplasty of the pip joint when either the:patient is in need of a revision of failed pip prosthesis(es); or patient expects to place his/her hands under loading situations which preclude the use of an alternative implant in the painful osteo-arthritic and post traumatic arthritic pip joint.
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